Actively Recruiting
Phase III Trial Comparing Niraparib Alone Versus Niraparib Plus Bevacizumab After Carboplatin-Taxane Chemotherapy in Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer
Led by AGO Study Group · Updated on 2025-09-10
970
Participants Needed
65
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
AGO Study Group
Lead Sponsor
E
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two treatment strategies for patients newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This international, multicenter, randomized, open Phase III trial compares carboplatinpaclitaxel chemotherapy followed by niraparib alone versus carboplatinpaclitaxel combined with bevacizumab followed by both bevacizumab and niraparib. The study includes patients with high-grade, non-mucinous, non-clear cell epithelial tumors at specific advanced stages who have had surgery or plan chemotherapy with interval debulking surgery. All patients receive an initial cycle of carboplatin and paclitaxel before randomization. After central testing of tumor BRCA status, participants are randomly assigned to one of two arms Arm 1 continues with five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years Arm 2 receives five cycles of carboplatin and paclitaxel plus bevacizumab, then maintenance bevacizumab for up to one year alongside daily niraparib for up to three years. This design aims to determine if adding bevacizumab improves outcomes over the standard treatment. Participants undergo frequent assessments including scans and laboratory tests to monitor progression-free survival and other health outcomes. Researchers also evaluate overall survival, time to additional therapies, treatment-related side effects, and quality of life up to several years after enrollment. Patients attend regular visits for treatment, monitoring, and completion of questionnaires, with safety follow-up 30 days after the last dose. The entire observation period can last up to 66 months after the last patient joins the trial.
CONDITIONS
Brief Title
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian, peritoneal, or fallopian tube cancer at FIGO stage IIIB-IV
- Have undergone upfront primary debulking surgery or plan to undergo chemotherapy with interval debulking surgery
- Available tumor samples for central BRCA testing prior to randomization
- Able to start systemic therapy within 8 weeks of cytoreductive surgery
- ECOG performance status of 0 or 1
- Estimated life expectancy greater than 3 months
- Adequate bone marrow function within specified timeframes prior to treatment
- Adequate coagulation parameters within specified timeframes prior to treatment
- Adequate liver and kidney function within specified timeframes prior to treatment
- Normal or controlled blood pressure (≤140/90 mmHg) measured within specified timeframes
- Negative pregnancy test for women of childbearing potential within 7 days prior to treatment
- Agreement to use effective contraception or abstain from heterosexual intercourse during treatment and for 6 months after last dose
- Willingness and ability to comply with study visits, treatments, tests, and questionnaires
You will not qualify if you...
- Non-epithelial ovarian tumors
- Ovarian tumors of low malignant potential or low grade tumors
- Planned intraperitoneal chemotherapy
- Other malignancies within 5 years prior to randomization except certain low-risk cancers
- Prior systemic treatment for ovarian cancer
- Prior treatment with PARP inhibitors
- Use of other anticancer therapies or radiotherapy during trial treatment
- Previous randomization in this trial
- Major surgery within 1 week before study treatment or incomplete recovery from major surgery
- History or suspicion of brain metastases or spinal cord compression
- Significant recent traumatic injury
- Recent cerebrovascular events within 6 months
- Recent thrombotic or hemorrhagic disorders within 3 months
- Uncontrolled neurological conditions
- Pregnant or breastfeeding women
- Recent participation in other investigational drug trials
- Known hypersensitivity to study drugs or their components
- Non-healing wounds, active ulcers, or bone fractures
- Significant cardiovascular disease or poorly controlled arrhythmias
- Pre-existing sensory or motor neuropathy grade ≥2
- History of nephrotic syndrome
- Persistent cancer-related bowel obstruction
- Recent gastrointestinal fistulas, perforation, bleeding, or insufficiency
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Other diseases or conditions that increase risk with trial drugs
- History or diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- Previous bone marrow or solid organ transplant
- Recent chronic use of high-dose aspirin or platelet aggregation inhibitors
- Poor medical risk due to serious uncontrolled disorders or infections
- Active hepatitis B or C
- History of Posterior Reversible Encephalopathy Syndrome
- Chronic inflammatory bowel disease requiring active treatment
Research Team
S
Sandra Polleis
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here